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Related Manuals for BioCare Medical ONCORE
Summary of Contents for BioCare Medical ONCORE
- Page 1 ONCORE Manual ™ Automated Slide Staining System www.biocare.net...
- Page 2 Biocare Medical Technical Support: 800-799-9499 Option 3 Customer Service: 800-799-9499 Option 2 Fax: 925-603-8080 Corporate Office: 60 Berry Drive Pacheco, CA 94553 www.biocare.net...
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Page 3: Table Of Contents
Packing List ...................................11 Use after Installation ..............................11 ONCORE System Software ..............................13 Software Features & Functions ............................13 Using the ONCORE Automated Slide Staining System Software ..................13 Logging in to the ONCORE System Software ........................13 ONCORE System Software Home Screen ..........................13 Prepare Labels ................................14 Load and Unload Slides ..............................15... - Page 4 Baking Slides Before Staining ............................44 Changing Software Text Language ........................... 44 System Utilities - Network Tab ............................45 System utilities - LIM Tab .............................. 45 ONCORE Maintenance ................................45 Recommended Tissue Placement Guidelines ........................46 Daily Maintenance ................................. 46 Weekly Maintenance ..............................47 Monthly Maintenance ..............................
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Page 5: Introduction
Warranty The ONCORE warranty is for 12 months from the day of instrument installation and covers all parts and labor when system service is performed solely by Biocare Medical. Warranty becomes invalid if equipment is abused, damaged, or improperly maintained by customer. The warranty is not transferable to any other party should the equipment be resold or transferred to another party by the customer. -
Page 6: Instrument Components
Instrument Components On Floor 1. System Door 2. Buffer Tubing and Carboy (on counter) 3. Hazardous Waste Tubing and Carboy (on floor) 4. Non-Hazardous Waste Tubing and Carboy (on floor) 5. On/Off Switch 6. Reagent Rack 7. RFID Reagent Vial Registration Position 8. - Page 7 Z - Head 1. Dispense Probe (Z1) 2. Extraction Probe (Z2) 3. Hazardous Station 4. Non-Hazardous Station 5. RFID System 6. 2D Matrix Scanner 2-Liter Waste Carboys The 2-liter buffer carboy is positioned on the left side of the instrument and is connected using the quick disconnect tubing connection included with the system.
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Page 8: Description Of Parts
System Door The ONCORE System Door allows access to the work platform. The System Door locks at the start of staining run. It must remain closed during the operation of the instrument as well as during any heating procedures such as Slide Baking or a Heater Check. -
Page 9: Z-Head
Prior to the start of each run, the software will display estimates of the required volume of wash buffer as well as the amount of waste the run is expected to generate. If there is insufficient wash buffer in the ONCORE Buffer Carboy connected to the buffer inlet or insufficient space in the ONCORE Waste Carboys, please correct this condition before continuing with the staining process. -
Page 10: Storage And Handling
Instrument Disposal If the ONCORE is to be removed from service and disposed of, the instrument must be disinfected using a 10% bleach solution through the fluid delivery and waste systems and all exposed surfaces disinfected using Lysol ® brand industrial cleaner before it is disposed of... -
Page 11: Installation Site Requirements
Maximum relative humidity 80%, non-condensing. Ventilation Do not block the vent openings on the instrument. Leave a minimum of 5 cm (2 in.) of space between the ONCORE Automated Slide Stainer and the wall, cabinets or other obstructions. Venting (exhaust) The instrument does not need special exhaust ventilation unless required by safety regulations when using certain reagents. -
Page 12: Support
Operate the power switch located on the rear of the instrument to power off the ONCORE Automated Staining System if there is ever any question as to whether the instrument is operating safely. -
Page 13: Instrument
Do not switch off the power to the ONCORE Automated Slide Stainer until all motion has stopped, the robotic arm is in the home position and the software has been exited. -
Page 14: Warning Symbols
Warning Symbols The following symbols may appear on the instrument and instrument labeling: Power Distributed By Consult Instructions for Use (consult operating instruction) Consult Accompanying Documents In-Vitro Diagnostic Medical Device Serial Number Authorized Representative European Community CE Marking Manufacturer... -
Page 15: System Installation
System Installation Packing List Ensure that the ONCORE Automated Staining System was received in good condition and includes all of its component parts. The ONCORE Automated Staining System includes the following components: ONCORE Automated Slide Stainer � � 1 USB cable & 1 power cord �... - Page 16 The power cable must be connected to the back of the computer. The USB-AB cables from the instrument, the label printer and the report printer must be connected to the back of the computer. The USB cables from the keyboard and the mouse must be connected to the back of the computer.
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Page 17: Oncore System Software
Supervisor and Technician level users. Using the ONCORE Automated Slide Staining System Software The ONCORE System Software is used to prepare labels, load and unload slides, start a run and access System Utilities and Reports. Logging in to the ONCORE System Software Double click the ONCORE System Software Icon from the desktop and the software will display the Login Screen. -
Page 18: Prepare Labels
Prepare Labels The Prepare Labels Module allows the user to enter the pertinent slide information prior to printing the slide labels. To use this feature select the ‘Prepare Labels’ button found along the top menu of the Home Screen. The ‘Slide Label Editor’ window will open. -
Page 19: Load And Unload Slides
Choose from the ‘Custom Group’ drop down to order an Antibody Protocol from a Custom Group of Available Protocols.* Select the desired Protocol from the list of Available Protocols. If a Positive Control or a Negative Control for that Protocol is desired, check the box to the left of ‘Positive’... -
Page 20: Scan Slides
Scan Slides The ‘Scan Slides’ button can be used to activate the ‘Scan Slides’ feature of the ‘Auto Start’ function independently. Note: If this option is chosen, the ‘Scan Reagents’ feature will not start automatically once slides are scanned. See ‘Scan Reagents’ section of the manual. Assign Protocols ‘Assign Protocols’... -
Page 21: Scan Reagents
Screen’ button located on the ‘Home Screen’ to clear all positions. Scan Reagents Warning! Remove caps from all reagent vials and properly seat the reagent rack in the ONCORE stainer to avoid the RFID antenna crashing into the vials and damaging the ONCORE system. -
Page 22: Clean Screen
Alternatively, click the ‘Delay Start Staining Process’ button to delay the run. The ‘Delay Start Slide Staining’ window will open. Enter the date and time corresponding to the desired run completion date and time. Click the ‘OK’ button. A ‘Slide Staining Process Start Time’ window will then display indicating when the run will begin as well as the ‘Time Left To Start’ countdown. -
Page 23: System Utilities - Tools
System Utilities - Tools The ‘System Utilities’ Module contains several features that allow the user to bake slides, clean the tubing, access reports and test the heaters. Upon clicking the ‘System Utilities’ button, the user may select from the following tabs: Tools, Editors, Security, Settings, Network and LIM. -
Page 24: Baking Slides
Baking Slides Users may use the ONCORE automated staining platform to perform the necessary baking of slides prior to initiating an IHC or � ISH protocol. When a user selects this option within the ‘Tools’ menu a ‘Baking Slides’ window will appear. -
Page 25: Load Slide Map File
Load Slide Map File � Note: Only accessible under ‘Supervisor’ level security log-in. � This function allows the user to recall slides from a previous run without having to re-enter the case/slide information. � To utilize this feature click the ‘Load Slide Map File’ button within the ‘Tools’ tab. �... -
Page 26: Sp1-Z1 Calibration
SP1-Z1 Calibration � The proper probe position should be centered on the X-axis and close to the posterior of the Y-axis of the port as illustrated below: Do not use this feature. Reserved for Biocare field Service Engineer. � SP1-Z2 Calibration �... -
Page 27: Tubing Cleaning
Tubing Cleaning � This function performs a cleaning of the tubing to clear any possible residual build up that may accumulate during the staining process. � It is required to perform the Tubing Clean after every 150 staining runs or no less than every six months. It is recommended that Tubing Cleaning be performed every 3 months for optimal performance. -
Page 28: Generate Reports
Generate Reports � This function allows access to the ONCORE Report Generator. � Click the ‘Generate Reports’ button to open the Report Generator. � Choose a report from the menu on the left, select the desired report from the drop down menu on the right and click the ‘Generate Report’... - Page 29 All reports can be exported or printed by utilizing that option while a report is displayed. � Click the Tools Menu to ‘Import Data Files’, ‘Set Default Report’ or ‘Configure Report Fields’. � Clicking ‘Import Data Files’ will import all data files for all runs performed on the system. This action occurs automatically �...
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Page 30: Initialize System
� If 'Reagent Layout Map' is selected, four fields may be configured and saved. These fields will print on the Reagent Layout Map Report. Each field can be printed in either Bold or Regular font. � If 'IHC Summary' is selected, user may choose to either show reagents on the IHC Summary by selecting ‘True’ or not show reagents (and only show slides) by selecting ‘False’. -
Page 31: Prime Pump Z1
The software will then display a ‘Heater Check’ window with a countdown timer of 20 minutes. � � Upon completion of the check, the software will display an indication if all heaters are functioning properly or alert the user to a possible faulty module. Prime Z1 and Z2 This feature allows the user to manually prime the Z1 (dispense) prove and Z2 (extract) probe in one click. -
Page 32: System Utilities - Editors
System Utilities – Editors Protocol Editor � Note: Only accessible under ‘Supervisor’ level security log-in. � The ‘Protocol Editor’ window displays all protocols currently programmed into the software. The protocols are separated into groups by detection system. A user may toggle between the different protocol templates by selecting their respective tabs found at the top of the ‘Protocol Editor’... -
Page 33: Ar (Antigen Retrieval) Option
AR (Antigen Retrieval) Option To allow for selection of different antigen retrieval solutions (AR1, AR2, AR3 or for the substitution of antigen retrieval with Buffer, an Enzyme or a Block. � AR1 is a high pH solution. AR2 is a low pH solution. �... -
Page 34: Antibody/Probe Incubation Time
Antibody / Probe Incubation Time a. The default antibody incubation time is 30 minutes. b. ISH probe incubation times range from one to four hours, depending on the Template chosen. Antibody / Probe Incubation Temperature a. The standard antibody incubation temperature is 25°C (ambient). b. -
Page 35: Negative Control Editor
Negative Control Editor Note: Only accessible under ‘Supervisor’ level security log-in. � � The system automatically creates a duplicate protocol for each Protocol in the database and assigns the “Universal Negative Control Serum” in place of the antibody to create a Negative Control protocol. When a Negative Control is ordered for a Protocol, the system runs an identical protocol except it substitutes the negative control serum assigned in the Negative Control Editor. -
Page 36: Reagent Editor
� To reset all Negative Control protocols to the manufacturer default of ‘Universal Negative’: � Click the “Reset” button found at the bottom of the ‘Negative Control Editor’ button. A confirmation window will appear. To accept, click the ‘Yes’ button. To return to the ‘Negative Control Editor’ without �... - Page 37 The user will then populate the ‘Name’ field with the name of the primary antibody or probe. This will simultaneously � transfer the same text into the ‘Protocol Name’ field. � If user would like to change the text within the ‘Protocol Name’ field to something other than the name entered for the primary antibody or probe.
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Page 38: Rfid Editor
Select ‘RFID Editor’ within the ‘Editors’ tab in the ‘System Utilities’ window. � � This will open the ‘RFID Tag Editor’ window. � The ‘ONCORE Tag Editor’ window has two columns of information fields on either side with the field titles located in the middle. - Page 39 � The column on the left side will display the information currently coded into a particular reagent vial RFID tag when read by the RFID Reader and the column on the right side contains the fields utilized by a user to enter information to be coded to the RFID tag. The user will enter information either manually or using the provided drop down menus within the column on the right.
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Page 40: Custom Group Editor
Custom Group Editor In the ONCORE System Software, users may create Custom Groups of protocols that are commonly used. The creation of a Custom Group will expedite the process of finding frequently used protocols from the complete list of antibodies/protocols. Panels may then be used as a shortcut to add multiple protocols to a case at one time. -
Page 41: Panel Editor
Alternatively, if a protocol was added to a Custom Group in error, the user may highlight the protocol to be removed from � the ‘Selected Protocols’ field and click the ‘Remove Protocol’ button. Once satisfied with all of the information entered, click ‘Save’ to save changes and then click ‘Return’ to close the ‘Edit �... -
Page 42: Change Protocol Template
After all deletions have been made the user must then click the ‘Return’ button to return to the ‘Editors’ window. Change Protocol Template Note: These settings will be configured by a qualified Biocare Representative and should not be altered unless specified to do � so by Biocare Medical Technical Support. -
Page 43: System Utilities - Security Tab
System Utilities - Security Tab The ‘Security’ Tab within the ‘System Utilities’ menu allows “Supervisor Level” users to change their password, to add new users and to modify user security level settings. The latter two are under User Administration. Note: “Technician Level” users will only be able to utilize the ‘Change Password’ option detailed below. �... - Page 44 � User Administration � This feature of the software allows a “Supervisor Level” user to add, delete, and/or modify the security settings of users. � Note: “Technician Level” users are blocked from accessing the ‘User Administration’ feature. � To Add or Delete a User: Click the ‘User Administration’...
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Page 45: System Utilities - Settings Tab
System Utilities - Settings Tab Baking Slide Settings Note: Only assessable using the “Supervisor” level log-in. � The ‘Baking Slide Settings’ button allows the user to modify the default temperature and time of the ‘Baking Slides’ feature � located within the ‘Tools’ menu. To change the settings, click the ‘Baking Slide Settings’... -
Page 46: 2D Barcode Format
2D Barcode Format � Note: Only assessable using the “Supervisor” level log-in. � The 2D Barcode Format allows users to change the configuration of the information printed on the slide labels. The following is an explanation of the information that may be altered on the slide labels using the ‘Barcode Label Options’ window. �... - Page 47 � After clicking the ‘Label Format’ button within the ‘Barcode Label Options’ window, the ‘Label Formater’ window will open. Users may select which text they would like displayed on the printed slide labels by choosing from the options provided � within the drop down menus for each field.
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Page 48: Check Heater Settings
ONCORE software. Baking Slides Before Staining � The ONCORE Automated Slide Stainer also offers an option of having the slides undergo the baking protocol prior to the start of a run. � To activate or deactivate this feature a user must select the ‘Settings’ tab within ‘System Utilities’ and check (or uncheck) the box labeled “Baking Slides Before Staining”. -
Page 49: Oncore Maintenance
Tissues placed or no staining. The following illustration demonstrates the active outside of the active staining area may result in sub-standard staining area recommended for performing IHC on the ONCORE or no staining. The illustration below highlights the active Automated Stainer. -
Page 50: Daily Maintenance
Note: Ensure there is no lint left behind on the Slide Chamber surfaces as this may compromise staining results. If glass shards are observed in the hinge area, use the ONCORE Chamber Cleaning Brush to remove the glass from the hinge area and then wipe away with an alcohol wipe or vacuum (not provided). -
Page 51: Weekly Maintenance
4. Click ‘Load Unload Slides’ button and place blank slides in all positions. Click ‘Slide Lids Down’ when finished. 5. Click ‘Scan Reagents’ button. 6. Load all vials from ONCORE Chamber Cleaning Kit. Make sure to fill the empty vial provided with DI Water. Fill the Buffer container and empty the Waste container. -
Page 52: Monthly Maintenance
Recommended: perform every 2 months for optimal performance. Tubing cleaning Run ‘Tubing Clean’ function to clear any possible residual buildup from the lines that may accumulate during the staining process. 1. Use ONCORE Tubing Clean Kit. 2. Click ‘System Utilities’. 3. Select ‘Tubing Clean’. -
Page 53: Troubleshooting
Troubleshooting Problem Possible Causes Solution Contact Technical Support to configure After system initialization, the XYZ motor Invalid robotic and slide module correct addresses for the robotic and and the slide module lids are not moving addresses were assigned slide modules Fill the buffer carboy and initialize system No staining, light staining, uneven Insufficient buffer in carboy... - Page 54 “Could not Open RFID Port” error Poor or no USB cable connection Secure the USB connections message between instrument and computer Contact Technical Support to configure Invalid COM Port was assigned the correct RFID COM port Unable to read an RFID tag Missing or defective RFID tag Replace Improv vial Contact Technical Support to replace...
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Page 55: Ordering Information
Xylene (could be replaced with xylene substitute, such as Slide Brite) SBT-G1 Ethanol or reagent alcohol Deionized or distilled water DS Enzyme ORI6049 Chamber Cleaning Kit ORI6031K Tubing Cleaning Kit ORI6036K * Biocare Medical Products: Refer to a Biocare Medical catalog or www.biocare.net for further information. -
Page 56: Terminology And Abbreviations
2-Liter Hazardous Waste Bottle with Cap ONC030-HW 2-Liter Buffer Bottle with Modified Cap, Fittings ONC004 Slide Chamber ONC005 70% Isopropyl Alcohol wipes, 100 count ONC099 ONCORE Chamber Cleaning Brush ONC103 ONCORE Reagent Rack ONC007 Terminology and Abbreviations Alkaline Phosphatase Antigen Retrieval Deoxyribonucleic acid... - Page 57 800.799.9499 60 Berry Drive Pacheco, CA 94553 www.biocare.net 904-017-032618...
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